CLONAZEPAM tablet

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

CLONAZEPAM (UNII: 5PE9FDE8GB) (CLONAZEPAM - UNII:5PE9FDE8GB)

Sẵn có từ:

Preferred Pharmaceuticals Inc.

INN (Tên quốc tế):

CLONAZEPAM

Thành phần:

CLONAZEPAM 0.5 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Clonazepam is useful alone or as an adjunct in the treatment of the Lennox-Gastaut syndrome (petit mal variant), akinetic, and myoclonic seizures. In patients with absence seizures (petit mal) who have failed to respond to succinimides, clonazepam may be useful. Clonazepam is indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-V. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. Panic disorder (DSM-V) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5

Tóm tắt sản phẩm:

Clonazepam tablets USP 0.5 mg are orange, round, flat faced, beveled edge, scored, debossed with “1” and “2” on one side and plain on other. They are supplied as follows: Bottles of 20       NDC 68788-7394-2 Bottles of 30       NDC 68788-7394-3 Bottles of 60       NDC 68788-7394-6 Bottles of 90       NDC 68788-7394-9 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. 10 0533 3 6007149 Issued February 2021 Repackaged By: Preferred Pharmaceuticals Inc.

Tình trạng ủy quyền:

Abbreviated New Drug Application

Tờ rơi thông tin

Preferred Pharmaceuticals Inc.
----------
MEDICATION GUIDE
MEDICATION GUIDE
CLONAZEPAM TABLETS USP C-IV
(KLOE-NA-ZA-PAM)
FOR ORAL USE
What is the most important information I should know about Clonazepam
tablets?
•
Clonazepam tablets are a benzodiazepine medicine. Taking
benzodiazepines with opioid
medicines, alcohol, or other central nervous system (CNS) depressants
(including street drugs) can
cause severe drowsiness, breathing problems (respiratory depression),
coma, and death. Get
emergency help right away if any of the following happens:
•
shallow or slowed breathing
•
breathing stops (which may lead to the heart stopping)
•
excessive sleepiness (sedation)
Do not drive or operate heavy machinery until you know how taking
clonazepam tablets and
opioids affects you.
•
Risk of abuse, misuse, and addiction. There is a risk of abuse,
misuse, and addiction with
benzodiazepines, including clonazepam tablets, which can lead to
overdose and serious side effects
including coma and death.
•
Serious side effects including coma and death have happened in people
who have abused or
misused benzodiazepines, including clonazepam tablets. These serious
side effects may also
include delirium, paranoia, suicidal thoughts or actions, seizures,
and difficulty breathing.
Call your healthcare provider or go to the nearest hospital emergency
room right away if you
get any of these serious side effects.
•
You can develop an addiction even if you take clonazepam tablets as
prescribed by your
healthcare provider.
•
Take clonazepam tablets exactly as your healthcare provider
prescribed.
•
Do not share your clonazepam tablets with other people.
•
Keep clonazepam tablets in a safe place and away from children.
•
Physical dependence and withdrawal reactions. Clonazepam tablets can
cause physical dependence
and withdrawal reactions.
•
Do not suddenly stop taking clonazepam tablets. Stopping clonazepam
tablets suddenly can
cause serious and life-threatening side effects, including, unusual
movements, responses, or
exp

Đặc tính sản phẩm

CLONAZEPAM- CLONAZEPAM TABLET
PREFERRED PHARMACEUTICALS INC.
----------
CLONAZEPAM TABLETS, USP
CIV
RX ONLY
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE,
MISUSE, AND ADDICTION; AND DEPENDENCE AND WITHDRAWAL
REACTIONS
•
•
•
DESCRIPTION
Clonazepam, a benzodiazepine, is available as scored tablets debossed
with “1” and “2”
containing 0.5 mg of clonazepam and unscored tablets debossed with
“C 1” on 1 mg
tablets and “C 2” on 2 mg tablets containing 1 mg or 2 mg of
clonazepam. Each tablet
contains anhydrous lactose, lactose monohydrate, magnesium stearate,
microcrystalline
cellulose and starch (corn), with the following colorants: 0.5 mg-FD&C
Yellow No. 6 Lake
and 1 mg- FD&C Blue No.2 Lake.
CONCOMITANT USE OF BENZODIAZEPINES AND OPIOIDS MAY RESULT IN
PROFOUND SEDATION, RESPIRATORY DEPRESSION, COMA, AND DEATH.
RESERVE CONCOMITANT PRESCRIBING OF THESE DRUGS FOR PATIENTS FOR
WHOM ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE. LIMIT DOSAGES
AND DURATIONS TO THE MINIMUM REQUIRED. FOLLOW PATIENTS FOR SIGNS
AND SYMPTOMS OF RESPIRATORY DEPRESSION AND SEDATION (SEE
WARNINGS AND PRECAUTIONS).
THE USE OF BENZODIAZEPINES, INCLUDING CLONAZEPAM, EXPOSES USERS TO
RISKS OF ABUSE, MISUSE, AND ADDICTION, WHICH CAN LEAD TO OVERDOSE OR
DEATH. ABUSE AND MISUSE OF BENZODIAZEPINES COMMONLY INVOLVE
CONCOMITANT USE OF OTHER MEDICATIONS, ALCOHOL, AND/OR ILLICIT
SUBSTANCES, WHICH IS ASSOCIATED WITH AN INCREASED FREQUENCY OF
SERIOUS ADVERSE OUTCOMES. BEFORE PRESCRIBING CLONAZEPAM AND
THROUGHOUT TREATMENT, ASSESS EACH PATIENT’S RISK FOR ABUSE,
MISUSE, AND ADDICTION (SEE WARNINGS)
THE CONTINUED USE OF BENZODIAZEPINES, INCLUDING CLONAZEPAM, MAY
LEAD TO CLINICALLY SIGNIFICANT PHYSICAL DEPENDENCE. THE RISKS OF
DEPENDENCE AND WITHDRAWAL INCREASE WITH LONGER TREATMENT DURATION
AND HIGHER DAILY DOSE. ABRUPT DISCONTINUATION OR RAPID DOSAGE
REDUCTION OF CLONAZEPAM AFTER CONTINUED USE MAY PRECIPITATE ACUTE
WITHDRAWAL REACTIONS, WHICH CAN BE LIFE-THREATENING. TO REDUCE THE
RISK OF WITHDRAWAL REACTIONS, USE A GRADUAL TAPER TO